Online Safety Community

January 2017 Blog Posts (22)

Water System Validation in Pharmaceuticals Industry 2017

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of…

Continue

Added by John Robinson on January 31, 2017 at 5:09am — No Comments

Statistics for the Non-Statistician: Is it necessary?

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant,…

Continue

Added by John Robinson on January 25, 2017 at 4:58am — No Comments

Recommended Practices for Anti-Retaliation Programs

WASHINGTON - The Occupational Safety and Health Administration today issued Recommended Practices for Anti-Retaliation Programs to help employers create workplaces in which workers feel comfortable voicing their concerns without fear of retaliation. The recommendations are intended to apply to all…

Continue

Added by Henry Wilter on January 24, 2017 at 6:34pm — No Comments

Management for Medical Device Industry

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.

While many global…

Continue

Added by John Robinson on January 23, 2017 at 7:46am — No Comments

Management systems should be expansive and versatile

Management systems should be expansive and versatile, as having such a system makes sense for organizations. A management system is a mechanism that helps streamline an organization’s day to day functioning without hassles. It should put the organization on the path it chooses to take by putting in place a set of documents that is prescriptive and hierarchical,…

Continue

Added by John Robinson on January 20, 2017 at 5:50am — No Comments

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects

Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.…

Continue

Added by Adam Fleming on January 20, 2017 at 5:19am — No Comments

Sweating Slab Syndrome Safety Hazards

Sweating Slab Syndrome presents many dangers in industrial facilities and other buildings that have concrete floors. 

Sweating Slab Syndrome is characterized by the regular formation of condensation on a concrete floor. Not only can this lead to slips and falls, but can also lead to mold growth and many other dangers.

Go Fan Yourself has created an infographic that highlights the dangers of Sweating Slab Syndrome and provides some tips for alleviating Sweating Slab…

Continue

Added by Nikki Heinkel on January 19, 2017 at 12:18pm — No Comments

Working at height is one of the UK's leading causes of workplace fatalities & injuries. These pointers will reduce risks & make working at height safer.

Working at height is the leading cause of workplace fatalities & injuries in the UK. In 2013/14, the Health and Safety Executive published statistics which showed that working at height was responsible for more workplace fatalities than any other professional activity. It also revealed that working at height was the…

Continue

Added by Alex on January 19, 2017 at 12:04pm — No Comments

Alternatives to AQL sampling plans do exist

Alternatives to AQL sampling plans do exist, but companies need to be aware of them and explore them. Acceptance Quality Limit, or AQL, is applied as a benchmark in most manufacturing organizations to inspect the quality of products they purchase. It is only when the product meets AQL that the receipt is acknowledged and the payment made.

So, what is AQL?

What is AQL? In simple terms, AQL, which expands to Acceptance Quality Limit, is what…

Continue

Added by Adam Fleming on January 19, 2017 at 5:06am — No Comments

FDA Regulation of Combination Products is important to understand

FDA regulation of combination products is a very important aspect to keep in mind for pharmaceutical manufacturers. This is because of the complex nature of combination products. The definition for combination products is set out in 21 CFR 3.2 (e). Combination products assume importance in the industry because they combine two more drugs from different categories. This is what makes them unique. If a product is made out of two or more drugs from the same category, it does…

Continue

Added by Adam Fleming on January 18, 2017 at 5:02am — No Comments

Post market surveillance needs to be robust to avoid penal regulatory action

Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.

Post market surveillance is, in simple terms, the monitoring of the performance and…

Continue

Added by Adam Fleming on January 17, 2017 at 6:56am — No Comments

Compliance for medical devices is a very expansive area for manufacturers of medical devices

Compliance for medical devices is a very broad and vast topic. When one talks of compliance for medical devices, one needs to keep in mind the various regulations that the FDA has put in place for manufacturers of medical devices to comply with. The FDA requires strict compliance with its laws and requirements because it is charged with the task of ensuring the…

Continue

Added by John Robinson on January 16, 2017 at 5:46am — No Comments

How to implement 21 CFR Part 11, which is about Compliance for Electronic Records and Signatures?

How to implement 21 CFR Part 11, the regulatory guideline which deals with compliance for electronic records and signatures, is a challenge for professionals in the medical devices and pharmaceutical industries. The FDA has set out 21 CFR Part 11 to help the regulated industries that come under its purview to structure their business processes…

Continue

Added by John Robinson on January 13, 2017 at 5:17am — No Comments

ISO 14971: 2012 and IEC 62304: 2006 mitigate risks in medical device software

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines…

Continue

Added by John Robinson on January 13, 2017 at 4:30am — No Comments

Regulatory Filing Requirements for medical devices in Japan

Japan is the world's third largest market for medical devices, after the US and Europe. Ironically, many of the world's medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are…

Continue

Added by John Robinson on January 12, 2017 at 4:51am — No Comments

Work tools: key stats and areas of concern

Although we all know intuitively that power tools can be exceptionally dangerous if used without due care and attention, it remains far too easy to fall into the trap of thinking that the ones we’re most accustomed to are somehow made safer by dint of our familiarity with them.

 

However, numerous eye-opening statistics have been gathered in recent years to…

Continue

Added by Alex on January 11, 2017 at 11:04am — No Comments

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of…

Continue

Added by John Robinson on January 11, 2017 at 5:01am — No Comments

HIPAA Security Rule

Though short in length,HIPAA Security Rule principles are well defined in some areas, but vague in some others, making implementation of these areas difficult.

HIPAA Security Rules are an offshoot of the Privacy Rule. While Privacy Rule concerns itself with Protected Health Information (PHI) in general, the HIPAA Security Rule (SR) concerns itself…

Continue

Added by John Robinson on January 10, 2017 at 4:41am — No Comments

Emerging Issues in Food Safety-Globally

The Global Food Safety Initiative is a private enterprise by those in the food industry aimed at offering guidance to the food industry for making food chain safer. This industry-driven initiative seeks to provide thought leadership on the various aspects of food and guides the food industry on implementing safety standards along all the points in the food…

Continue

Added by John Robinson on January 9, 2017 at 6:42am — No Comments

GMP Compliance for Pharmaceutical Laboratories

In order to ensure GMP compliance, pharmaceutical laboratories have to devise a holistic and long term plan that covers all aspects of the laboratory's activities.

Good Manufacturing Practices (GMP) requirements for laboratories have been set out by various regulatory bodies. The aim of GMP compliance for a pharmaceutical laboratory is to ensure…

Continue

Added by John Robinson on January 9, 2017 at 6:00am — No Comments

Monthly Archives

2020

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2005

1999

Take our poll!

Take our poll!

Latest Activity

TrojanMotors posted a blog post

Choosing the Best Auto Electrical Services Pakuranga for your Vehicle

Every auto electrical & mechanical services have their objectives and maintain the life of your vehicle. What's more, there focuses individually stays on to accomplish your motor vehicle life. At the point when you are in search of quality, you will be best put in the result that you work with specialists who guarantee you quality. Also, they who will assist you with producing the correct push towards accomplishing your set destinations. As an organisation, you should just work with just…See More
17 hours ago
Profile IconTrojanMotors, RefluxMD, Inc. - Gerd Diet, Smealtskel and 3 more joined Online Safety Community
17 hours ago
gautham posted an event

Expert level business analyst online course with free demo at hyderabad,

January 20, 2020 at 9am to January 31, 2020 at 9pm
About Business analyst,There are various reasons while organizations are using business intelligence and analytical tools. In Business intelligence, we can perform all the faster reports, analysis and planning. Business analyst has taken better business decisions and improve the data quality. get more through business analyst courseAbout Our CompanyOnlineituguru is one of the best training…See More
17 hours ago
Smealtskel posted a blog post

Wow Gold

World of warcraft is an amazing online video game. It is one of the highly played and liked gameplay by people. Wow is designed with incredible features which makes the gameplay much more interesting and exciting. The missions of the game are not easily completed by anyone so wow gold is introduced by gaming industry.
17 hours ago

Forum

Outlook PST Recover 2 Replies

If your outlook data corrupted which is a part of the Ms Office Suit commonly use as an email application. It includes some email items like calendar, tasks, contact and other items. You may use any…Continue

Tags: outlook, recover, recovery, pst

Started by colin munro. Last reply by treykelly 20 hours ago.

eSoftTools NSF to PST Converter 1 Reply

Here I am prescribing eSoftTools NSF to PST Converter programming that safely performs to recover NSF…Continue

Started by Irisrose. Last reply by treykelly 20 hours ago.

How to convert NSF data files to Outlook PST 7 Replies

If you want to convert the NSF data to Outlook PST and other formats. If you want to follow the 2 way, definitely you can convert all NSF data to PST. The first method is Manual.Manual method is free…Continue

Tags: lotus, notes, outlook, converter, pst

Started by Max Beckham. Last reply by treykelly 20 hours ago.

Zip password recovery

Recover zip file password with the help of the eSoftTools zip password recovery software instantly.…Continue

Tags: zipx, unlocker, break, file, unlock

Started by Izabelaanna yesterday.

How EDB to PST Converter software important for Exchange user? 2 Replies

Do you know how Exchange server is important for Exchange user? You get know by reading this articleThis article will give you the brief idea of how…Continue

Started by Rose Watt. Last reply by jan smith yesterday.

Badge

Loading…

© 2020   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service